FENTANYL 100 ug/h Patch
Other active recalls for Fentanyl (different manufacturers) — 1 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Opioid Agonist class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Fentanyl patches are used to relieve severe pain. Fentanyl is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain.
Read the full MedlinePlus article ↗- The fentanyl patch releases a steady, strong amount of opioid through your skin over 72 hours. If your body isn't already used to opioids, that level of fentanyl can slow your brea...
- Why do I have to already be on opioids before I can use this patch?
- Apply it to clean, dry, flat skin — your upper arm or chest are common spots — and press it firmly in place. Wear it for exactly 72 hours, then remove it and apply a new one to a d...
- No — please don't throw used patches in the regular trash. A used patch still contains a large amount of active fentanyl, enough to seriously harm or kill a child or an adult who d...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Fentanyl — tap one for details:
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 92RU3N3Y1O
Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
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UNII 9N5G1G3D3H
A silicone-based polymer blend used as a glidant and anti-caking agent. It reduces friction between particles and helps powders flow smoothly during tablet or capsule manufacturing.
2 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $18.137 | $90.69 / 5 patch |
| Medicaid paysCMS SDUD · 12 mo | $16.17 | $80.85 / 5 patch |
| Medicare drug plans payPart D · Q2 2026 | $20.32 | $101.59 / 5 patch |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Fentanyl 100 ug/hthis 00378-9124-98 | Mylan | 5 patches | $18.137 | AB | Availability likely | — |
| Fentanyl Transdermal 100 ug/h 00406-9100-76 | SpecGx | 5 patches | $18.137 | AB | Availability likely | — |
| Fentanyl system 100 ug 47781-0428-47 | ALVOGEN | 5 patches | $18.137 | AB | Availability likely | — |
| Fentanyl 100 ug/h 50742-0556-05 | INGENUS | 5 patches | $18.137 | AB | Availability likely | — |
| Fentanyl 100 ug/h 03215-7708-05 | Aveva | 5 patches | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00378-9124-98 You're viewing this | 5 POUCH in 1 CARTON (0378-9124-98) / 1 PATCH in 1 POUCH (0378-9124-16) / 72 h in 1 PATCH | 2005-01-31 | Active |
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF FENTANYL TRANSDERMAL SYSTEM Addiction, Abuse, and Misuse Because the use of fentanyl transdermal system exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.1) ] . Life-threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of fentanyl transdermal system, especially during initiation or following a dosage increase.
To reduce the risk of respiratory depression, proper dosing and titration of fentanyl transdermal system is essential [see Warnings and Precautions (5.2) ] . Accidental Exposure Accidental exposure of even one dose of fentanyl transdermal system, especially in children, can result in a fatal overdose of fentanyl [see Warnings and Precautions (5.3) ] . Deaths due to an overdose of fentanyl have occurred when children and adults were accidentally exposed to fentanyl transdermal system.
Strict adherence to the recommended handling and disposal instructions is for the utmost importance to prevent accidental exposure [see Warnings and Precautions (5.3) ] . Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of fentanyl transdermal system and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. [see Warnings and Precautions (5.4) , Drug Interactions (7) ] .
Neonatal Opioid Withdrawal Syndrome (NOWS) Advise pregnant women using opioids for an extended period of time of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery [see Warnings and Precautions (5.5) ] . Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription [see Warnings and Precautions (5.6) ] .
Cytochrome P450 3A4 Interaction The concomitant use of fentanyl transdermal system with all cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in fentanyl plasma concentration. Monitor patients receiving fentanyl transdermal system and any CYP3A4 inhibitor or inducer [see Warnings and Precautions (5.7) and Clinical Pharmacology (12.3) ] .
Risk of Increased Fentanyl Absorption with Application of External Heat Exposure of the fentanyl transdermal system application site and surrounding area to direct external heat sources, such as heating pads or electric blankets, heat or tanning lamps, sunbathing, hot baths, saunas, hot tubs, and heated water beds may increase fentanyl absorption and has resulted in fatal overdose of fentanyl. Warn patients to avoid exposing the application site and surrounding area to direct external heat sources [see Warnings and Precautions (5.8) ] .
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF FENTANYL TRANSDERMAL SYSTEM See full prescribing information for complete boxed warning. • Fentanyl transdermal system exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing and reassess regularly for t…
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Fentanyl transdermal system is indicated for the management of severe and persistent pain in opioid tolerant patients, that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid.
Limitations of Use: • Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1) ] , reserve opioid analgesics, including fentanyl transdermal system for use in patients for whom alternative treatment options are ineffective, not tolerated or would be otherwise inadequate to provide sufficient management of pain. • Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic.
Fentanyl transdermal system contains fentanyl, an opioid agonist, and is indicated for the management of severe and persistent pain in opioid tolerant patients, that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. ( 1 ) Patients considered opioid-tolerant are those taking, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid.
( 2.1 ) Limitations of use: • Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including fentanyl transdermal system, for use in patients for whom alternative treatment options are ineffective, not tolerated or would be otherwise inadequate to provide sufficient management of pain. ( 1 , 5.1 ) • Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION • Fentanyl transdermal system should be prescribed only by healthcare providers who are knowledgeable about the use of extended-release/long-acting opioids and how to mitigate the associated risks. ( 2.1 ) • Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals. Reserve titration to higher doses of fentanyl transdermal system for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks.
( 2.1 , 5 ) • Initiate the dosing regimen for each patient individually, taking into account the patient’s underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse. ( 5.1 ) • Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with fentanyl transdermal system. Consider this risk when selecting an initial dose and when making dose adjustments.
( 2.1 , 5.12 ) • Discuss opioid overdose reversal agents and options for acquiring them with the patient and/or caregiver, both when initiating and renewing treatment with fentanyl transdermal system, especially if the patient has additional risk factors for overdose, or close contacts at risk for exposure and overdose. ( 2.2 , 5.1 , 5.2 , 5.4 ) • Initial dose selection: consult conversion instructions. ( 2.3 ) • Periodically reassess patients receiving fentanyl transdermal system to evaluate the continued need for opioid analgesics to maintain pain control, for the signs or symptoms of adverse reactions, and for the development of addiction, abuse, or misuse.
( 2.4 ) • Each transdermal system is intended to be worn continuously for up to 72 hours. ( 2.3 , 2.7 ) • Adhere to instructions concerning administration and disposal of fentanyl transdermal system. ( 2.7 , 2.8 ) • Mild to moderate hepatic and renal impairment: Initiate treatment with one half the usual starting dose, titrate slowly, and monitor for signs of respiratory and central nervous system depression.
( 2.5 , 2.6 ) • Do not rapidly reduce or abruptly discontinue fentanyl transdermal system in a physically dependent patient because rapid reduction or abrupt discontinuation of opioid analgesics has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide. ( 2.9 , 5.21 )
2.1Important Dosage and Administration Instructions • Fentanyl transdermal system should be prescribed only by healthcare professionals who are knowledgeable about the use of extended-release/long-acting opioids and how to mitigate the associated risks. • Due to the risk of respiratory depression, fentanyl transdermal system is only indicated for use in patients who are already opioid-tolerant. Discontinue or taper all other extended-release opioids when beginning fentanyl transdermal system therapy. As fentanyl transdermal system is only for use in opioid-tolerant patients, do not begin any patient on fentanyl transdermal system as the first opioid [see Indications and Usage (1) ] . • Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals [see Warnings and Precautions (5) ] .
Because the risk of overdose increases as opioid doses increase, reserve titration to higher doses of fentanyl transdermal system for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks. • Initiate the dosing regimen for each patient individually, taking into account the patient’s underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.1) ] . • Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with fentanyl tr…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Fentanyl Transdermal System is available as 12 mcg/hour*, 25 mcg/hour, 37.5 mcg/hour, 50 mcg/hour, 62.5 mcg/hour, 75 mcg/hour, 87.5 mcg/hour or 100 mcg/hour of fentanyl. • The 12 mcg/hour* (system size 3.13 cm 2 ) transdermal system consists of a translucent rectangular patch with rounded corners, printed with “Fentanyl 12 mcg/hr” and diagonal stripes in blue ink, on a removable release liner. The patch is overlaid and underlaid with additional release liners, and is contained in a square pouch.
The pouch is labeled with the lot number and expiration date. • The 25 mcg/hour (system size 6.25 cm 2 ) transdermal system consists of a translucent rectangular patch with rounded corners, printed with “Fentanyl 25 mcg/hr” and diagonal stripes in blue ink, on a removable release liner. The patch is overlaid and underlaid with additional release liners, and is contained in a square pouch. The pouch is labeled with the lot number and expiration date. • The 37.5 mcg/hour (system size 9.38 cm 2 ) transdermal system consists of a translucent rectangular patch with rounded corners, printed with “Fentanyl 37.5 mcg/hr” and diagonal stripes in blue ink, on a removable release liner.
The patch is overlaid and underlaid with additional release liners, and is contained in a square pouch. The pouch is labeled with the lot number and expiration date. • The 50 mcg/hour (system size 12.5 cm 2 ) transdermal system consists of a translucent rectangular patch with rounded corners, printed with “Fentanyl 50 mcg/hr” and diagonal stripes in blue ink, on a removable release liner. The patch is overlaid and underlaid with additional release liners, and is contained in a square pouch.
The pouch is labeled with the lot number and expiration date. • The 62.5 mcg/hour (system size 15.63 cm 2 ) transdermal system consists of a translucent rectangular patch with rounded corners, printed with “Fentanyl 62.5 mcg/hr” and diagonal stripes in blue ink, on a removable release liner. The patch is overlaid and underlaid with additional release liners, and is contained in a square pouch. The pouch is labeled with the lot number and expiration date. • The 75 mcg/hour (system size 18.75 cm 2 ) transdermal system consists of a translucent rectangular patch with rounded corners, printed with “Fentanyl 75 mcg/hr” and diagonal stripes in blue ink, on a removable release liner.
The patch is overlaid and underlaid with additional release liners, and is contained in a square pouch. The pouch is labeled with the lot number and expiration date. • The 87.5 mcg/hour (system size 21.88 cm 2 ) transdermal system consists of a translucent rectangular patch with rounded corners, printed with “Fentanyl 87.5 mcg/hr” and diagonal stripes in blue ink, on a removable release liner. The patch is overlaid and underlaid with additional release liners, and is contained in a square pouch.
The pouch is labeled with the lot number and expiration date. • The 100 mcg/hour (system size 25 cm 2 ) transdermal system consists of a translucent rectangular patch with rounded corners, printed with “Fentanyl 100 mcg/hr” and diagonal stripes in blue ink, on a removable release liner. The patch is overlaid and underlaid with additional release liners, and is contained in a square pouch. The pouch is labeled with the lot number and expiration date. *This lowest strength is designated as 12 mcg/hour (however, the actual strength is 12.5 mcg/hour) to distinguish it from a possible 125 mcg/hour dosage that could be prescribed by using multiple transdermal systems.
Transdermal system : 12 mcg/hour, 25 mcg/hour, 37.5 mcg/hour, 50 mcg/hour, 62.5 mcg/hour, 75 mcg/hour, 87.5 mcg/hour, 100 mcg/hour. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Fentanyl transdermal system is contraindicated in: • patients who are not opioid-tolerant. • the management of acute or intermittent pain, or in patients who require opioid analgesia for a short period of time. • the management of post-operative pain, including use after out-patient or day surgeries, (e.g., tonsillectomies). • the management of mild pain. • patients with significant respiratory depression [see Warnings and Precautions (5.12) ] . • in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.12) ] . • in patients with known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.19) ] . • in patients with hypersensitivity to fentanyl (e.g., anaphylaxis) or any components of the transdermal system [see Adverse Reactions (6.2) ] . • Opioid non-tolerant patients.
( 4 ) • Acute or intermittent pain, postoperative pain, mild pain. ( 4 ) • Significant respiratory depression. ( 4 ) • Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment.
( 4 ) • Known or suspected gastrointestinal obstruction, including paralytic ileus. ( 4 ) • Known hypersensitivity to fentanyl or any of the components of the transdermal system. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Risk of Increased Fentanyl Absorption with Elevated Body Temperature : Regularly evaluate patients with fever closely for sedation and respiratory depression and reduce the dose if necessary. Warn patients to avoid strenuous exertion that may lead to increased body temperature. ( 5.9 ) • Opioid Induced Hyperalgesia (OIH) and Allodynia : Opioid-Induced Hyperalgesia (OIH) occurs when an opioid analgesic paradoxically causes an increase in pain, or an increase in sensitivity to pain.
If OIH is suspected, carefully consider appropriately decreasing the dose of the current opioid analgesic, or opioid rotation. ( 5.10 ) • Serotonin Syndrome with Concomitant Use of Serotonergic Drugs : Potentially life-threatening condition could result from concomitant serotonergic drug administration. Discontinue fentanyl transdermal system immediately if serotonin syndrome is suspected.
( 5.11 ) • Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients : Regularly evaluate closely, particularly during initiation and titration. ( 5.12 ) • Adrenal Insufficiency : If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. ( 5.13 ) • Severe Hypotension : Regularly evaluate during dose initiation and titration.
Avoid the use of fentanyl transdermal system in patients with circulatory shock. ( 5.14 ) • Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury or Impaired Consciousness : Monitor for sedation and respiratory depression. Avoid use of fentanyl transdermal system in patients with impaired consciousness or coma.
( 5.15 )
5.1Addiction, Abuse, and Misuse Fentanyl transdermal system contains fentanyl, an opioid agonist and a Schedule II controlled substance. As an opioid, fentanyl transdermal system exposes users to the risks of addiction, abuse, and misuse. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed fentanyl transdermal system.
Addiction can occur at recommended doses and if the drug is misused or abused. The risk of opioid-related overdose or overdose related death is increased with higher opioid doses, and this risk persists over the course of therapy. In postmarketing studies, addiction, abuse, misuse, and fatal and non-fatal opioid overdose were observed in patients with long-term opioid use [see Adverse Reactions (6.2) ] .
Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing fentanyl transdermal system, and reassess all patients receiving fentanyl transdermal system for the development of these behaviors and conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient.
Patients at increased risk may be prescribed opioids such as fentanyl transdermal system, but use in such patients necessitates intensive counseling about the risks and proper use of fentanyl transdermal system along with frequent reevaluation for signs of addiction, abuse, and misuse. Consider recommending or prescribing an opioid overdose reversal agent [see Dosage and Administration (2.2) , Warnings and Precautions (5.2) ] . Abuse or misuse of fentanyl transdermal system by placing it in the mouth, chewing it, swallowing it, or using it in ways other than indicated may cause choking, overdose, and death [see Overdosage (10) ] .
Opioids are sought for nonmedical use and are subject to diversion from legitimate prescribed use. Consider these risks when prescribing or dispensing fentanyl transdermal system. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on careful storage of the drug du…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: • Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1) ] • Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2) ] • Accidental Exposure [see Warnings and Precautions (5.3) ] • Interactions with Benzodiazepines or Other Central Nervous System Depressants [see Warnings and Precautions (5.4) ] • Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.5) ] • Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.10) ] • Serotonin Syndrome [see Warnings and Precautions (5.11) ] • Adrenal Insufficiency [see Warnings and Precautions (5.13) ] • Severe Hypotension [see Warnings and Precautions (5.14) ] • Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.19) ] • Seizures [see Warnings and Precautions (5.20) ] • Withdrawal [see Warnings and Precautions (5.21) ] Most common adverse reactions (≥ 5%) are nausea, vomiting, somnolence, dizziness, insomnia, constipation, hyperhidrosis, fatigue, feeling cold, anorexia, headache, and diarrhea.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of fentanyl transdermal system was evaluated in 216 patients who took at least one dose of fentanyl transdermal system in a multicenter, double-blind, randomized, placebo-controlled clinical trial of fentanyl transdermal system.
This trial examined patients over 40 years of age with severe pain induced by osteoarthritis of the hip or knee and who were in need of and waiting for joint replacement. The most common adverse reactions (≥ 5%) in a double-blind, randomized, placebo-controlled clinical trial in patients with severe pain were nausea, vomiting, somnolence, dizziness, insomnia, constipation, hyperhidrosis, fatigue, feeling cold, and anorexia. Other common adverse reactions (≥ 5%) reported in clinical trials in patients with chronic malignant or nonmalignant pain were headache and diarrhea.
Adverse reactions reported for ≥ 1% of fentanyl transdermal system-treated patients and with an incidence greater than placebo-treated patients are shown in Table 3. The most common adverse reactions that were associated with discontinuation in patients with pain (causing discontinuation in ≥ 1% of patients) were depression, dizziness, somnolence, headache, nausea, vomiting, constipation, hyperhidrosis, and fatigue. Table 3: Adverse Reactions Reported by ≥ 1% of Fentanyl Transdermal System-treated Patients and With an Incidence Greater Than Placebo-treated Patients in 1 Double-Blind, Placebo-Controlled Clinical Trial of Fentanyl Transdermal System System/Organ Class Adverse Reaction Fentanyl Transdermal System % (N = 216) Placebo % (N = 200) Cardiac disorders Palpitations 4 1 Ear and labyrinth disorders Vertigo 2 1 Gastrointestinal disorders Nausea 41 17 Vomiting 26 3 Constipation 9 1 Abdominal pain upper 3 2 Dry mouth 2 0 General disorders and administration site conditions Fatigue 6 3 Feeling cold 6 2 Malaise 4 1 Asthenia 2 0 Edema peripheral 1 1 Metabolism and nutrition disorders Anorexia 5 0 Musculoskeletal and connective tissue disorders Muscle spasms 4 2 Nervous system disorders Somnolence 19 3 Dizziness 10 4 Psychiatric disorders Insomnia 10 7 Depression 1 0 Skin and subcutaneous tissue disorders Hyperhidrosis 6 1 Pruritus 3 2 Rash 2 1 Adverse reactions not reported in Table 3 that were reported by ≥ 1% of fentanyl transdermal system-treated adult and pediatric patients (N = 1854) in 11 controlled and uncontrolled clinical trials of fentanyl transdermal system used for the t…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Table 6 includes clinically significant drug interactions with fentanyl transdermal system. Table 6: Clinically Significant Drug Interactions with Fentanyl Transdermal System Inhibitors of CYP3A4 Clinical Impact: The concomitant use of fentanyl transdermal system and CYP3A4 inhibitors can increase the plasma concentration of fentanyl, resulting in increased or prolonged opioid effects particularly when an inhibitor is added after a stable dose of fentanyl transdermal system is achieved [see Warnings and Precautions (5.7) ] .
After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the fentanyl plasma concentration will decrease [see Clinical Pharmacology (12.3) ] , resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to fentanyl. Intervention: If concomitant use is necessary, consider dosage reduction of fentanyl transdermal system until stable drug effects are achieved. Evaluate patients at frequent intervals for respiratory depression and sedation.
If a CYP3A4 inhibitor is discontinued, consider increasing the fentanyl transdermal system dosage until stable drug effects are achieved. Assess for signs of opioid withdrawal. Examples: Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), protease inhibitors (e.g., ritonavir), grapefruit juice CYP3A4 Inducers Clinical Impact: The concomitant use of fentanyl transdermal system and CYP3A4 inducers can decrease the plasma concentration of fentanyl [see Clinical Pharmacology (12.3) ] , resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to fentanyl [see Warnings and Precautions (5.7) ] .
After stopping a CYP3A4 inducer, as the effects of the inducer decline, the fentanyl plasma concentration will increase [see Clinical Pharmacology (12.3) ] , which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression. Intervention: If concomitant use is necessary, consider increasing the fentanyl transdermal system dosage until stable drug effects are achieved. Assess for signs of opioid withdrawal.
If a CYP3A4 inducer is discontinued, consider fentanyl transdermal system dosage reduction and evaluate patients at frequent intervals for signs of respiratory depression and sedation. Examples: Rifampin, carbamazepine, phenytoin Benzodiazepines and Other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death.
Intervention: Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Inform patients and caregivers of the potential interaction, educate them on the signs and symptoms of respiratory depression (including sedation).
If concomitant use is warranted, consider recommending or prescribing an opioid overdose reversal agent [see Dosage and Administration (2.2) , Warnings and Precautions (5.1 , 5.2 , 5.4) ] . Examples: Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), other opioids, alcohol. Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome [see Warnings and Precautions (5.11) ] .
Intervention: If concomitant use is warranted, frequently evaluate the patient, particularly during treatment initiation and dose adjustment. Discontinue fentanyl transdermal system if serotonin syndrome is suspected. Examples: Selective serotonin reuptake inhibitors (SSRIs), serotonin a…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS • Pregnancy : May cause fetal harm. ( 8.1 ) • Lactation : Not recommended. ( 8.2 ) • Severe Hepatic and Renal Impairment : Use not recommended. ( 8.6 , 8.7 )
8.1Pregnancy Risk Summary Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.5) ] . Available data with fentanyl transdermal system in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, fentanyl administration to pregnant rats during organogenesis was embryocidal at doses within the range of the human recommended dosing.
When administered during gestation through lactation fentanyl administration to pregnant rats resulted in reduced pup survival and developmental delays at doses within the range of the human recommended dosing. No evidence of malformations were noted in animal studies completed to date [see Data ] . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Use of opioid analgesics for an extended period of time during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth.
Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see Warnings and Precautions (5.5) ] .
Labor or Delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. An opioid overdose reversal agent, such as naloxone or nalmefene, must be available for reversal of opioid-induced respiratory depression in the neonate. Fentanyl transdermal system is not recommended for use in pregnant women during or immediately prior to labor, when use of shorter-acting analgesics or other analgesic techniques are more appropriate.
Opioid analgesics, including fentanyl transdermal system, can prolong labor through actions that temporarily reduce the strength, duration, and frequency of uterine contractions. However, this effect is not consistent and may be offset by an increased rate of cervical dilatation, which tends to shorten labor. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression.
Data Human Data There are no adequate and well-controlled studies in pregnant women. Fentanyl transdermal system should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Chronic maternal treatment with fentanyl during pregnancy has been associated with transient respiratory depression, behavioral changes, or seizures characteristic of neonatal abstinence syndrome in newborn infants.
Symptoms of neonatal respiratory or neurological depression were no more frequent than expected in most studies of infants born to women treated acutely during labor with intravenous or epidural fentanyl. Transient neonatal muscular rigidity has been observed in infants whose mothers were treated with intravenous fentanyl. Animal Data No evidence of malformations or adverse effects on the fetus was reported in a published study in which pregnant rats were administered fent…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.5) ] . Available data with fentanyl transdermal system in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, fentanyl administration to pregnant rats during organogenesis was embryocidal at doses within the range of the human recommended dosing.
When administered during gestation through lactation fentanyl administration to pregnant rats resulted in reduced pup survival and developmental delays at doses within the range of the human recommended dosing. No evidence of malformations were noted in animal studies completed to date [see Data ] . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Use of opioid analgesics for an extended period of time during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth.
Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see Warnings and Precautions (5.5) ] .
Labor or Delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. An opioid overdose reversal agent, such as naloxone or nalmefene, must be available for reversal of opioid-induced respiratory depression in the neonate. Fentanyl transdermal system is not recommended for use in pregnant women during or immediately prior to labor, when use of shorter-acting analgesics or other analgesic techniques are more appropriate.
Opioid analgesics, including fentanyl transdermal system, can prolong labor through actions that temporarily reduce the strength, duration, and frequency of uterine contractions. However, this effect is not consistent and may be offset by an increased rate of cervical dilatation, which tends to shorten labor. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression.
Data Human Data There are no adequate and well-controlled studies in pregnant women. Fentanyl transdermal system should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Chronic maternal treatment with fentanyl during pregnancy has been associated with transient respiratory depression, behavioral changes, or seizures characteristic of neonatal abstinence syndrome in newborn infants.
Symptoms of neonatal respiratory or neurological depression were no more frequent than expected in most studies of infants born to women treated acutely during labor with intravenous or epidural fentanyl. Transient neonatal muscular rigidity has been observed in infants whose mothers were treated with intravenous fentanyl. Animal Data No evidence of malformations or adverse effects on the fetus was reported in a published study in which pregnant rats were administered fentanyl continuously via subcutaneously implanted osmotic minipumps at doses of 10, 100, or 500 mcg/kg/day starting 2‑weeks prior to breeding and throughout pregnancy.
The high dose was appro…
🧒 Pediatric Use ▾
8.4Pediatric Use The safety of fentanyl transdermal system was evaluated in three open-label trials in 289 pediatric patients with chronic pain, 2 years of age through 18 years of age. Starting doses of 25 mcg/h and higher were used by 181 patients who had been on prior daily opioid doses of at least 45 mg/day of oral morphine or an equianalgesic dose of another opioid. Initiation of fentanyl transdermal system therapy in pediatric patients taking less than 60 mg/day of oral morphine or an equianalgesic dose of another opioid has not been evaluated in controlled clinical trials.
The safety and effectiveness of fentanyl transdermal system in children under 2 years of age have not been established. To guard against excessive exposure to fentanyl transdermal system by young children, advise caregivers to strictly adhere to recommended fentanyl transdermal system application and disposal instructions [see Dosage and Administration (2.7) , (2.8) and Warnings and Precautions (5.3) ] .
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of fentanyl transdermal system did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Data from intravenous studies with fentanyl suggest that the elderly patients may have reduced clearance and a prolonged half-life. Moreover, elderly patients may be more sensitive to the active substance than younger patients. A study conducted with the fentanyl transdermal system in elderly patients demonstrated that fentanyl pharmacokinetics did not differ significantly from young adult subjects, although peak serum concentrations tended to be lower and mean half-life values were prolonged to approximately 34 hours [see Clinical Pharmacology (12.3) ] .
Respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration. Titrate the dosage of fentanyl transdermal system slowly in geriatric patients and frequently reevaluate the patient for signs of central nervous system and respiratory depression [see Warnings and Precautions (5.12) ] . Fentanyl is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function.
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to regularly evaluate renal function.
🆘 Overdosage ▾
10 OVERDOSAGE Clinical Presentation: Acute overdose with fentanyl transdermal system can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and in some cases, pulmonary edema, bradycardia, hypotension, hypoglycemia, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations [see Clinical Pharmacology (12.2) ] . Toxic leukoencephalopathy has been reported after opioid overdose and can present hours, days, or weeks after apparent recovery from the initial intoxication.
Treatment of Overdose: Give primary attention to the reestablishment of a patent airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life support measures.
Once stable, examine the patient and ensure that all fentanyl transdermal systems have been removed. For clinically significant respiratory or circulatory depression secondary to opioid overdose, administer an opioid overdose reversal agent such as naloxone or nalmefene. Because the duration of opioid reversal is expected to be less than the duration of action of fentanyl in fentanyl transdermal system, carefully monitor the patient until spontaneous respiration is reliably reestablished.
After fentanyl transdermal system removal, serum fentanyl concentrations decline gradually, falling about 50% in approximately 20‒27 hours. Therefore, management of an overdose must be monitored accordingly, at least 72 to 96 hours beyond the overdose. In an individual physically dependent on opioids, administration of the recommended usual dosage of the opioid overdose reversal agent will precipitate an acute withdrawal syndrome.
The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the reversal agent administered. If a decision is made to treat serious respiratory depression in the physically-dependent patient, administration of the reversal agent should be initiated with care and by titration with smaller than usual doses of the reversal agent.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Fentanyl is an opioid agonist. Fentanyl interacts predominately with the opioid mu-receptor. These mu-binding sites are distributed in the human brain, spinal cord, and other tissues.
12.2Pharmacodynamics Effects on the Central Nervous System Fentanyl produces respiratory depression by direct action on brain stem respiratory centers. The respiratory depression involves a reduction in the responsiveness of the brain stem respiratory centers to both increases in carbon dioxide tension and electrical stimulation. Fentanyl causes miosis, even in total darkness.
Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origins may produce similar findings). Marked mydriasis rather than miosis may be seen due to hypoxia in overdose situations. In clinical trials of 357 non-opioid tolerant subjects treated with fentanyl transdermal system, 13 subjects experienced hypoventilation.
Hypoventilation was manifested by respiratory rates of less than 8 breaths/minute or a pCO 2 greater than 55 mm Hg. In these studies, the incidence of hypoventilation was higher in nontolerant women (10) than in men (3) and in subjects weighing less than 63 kg (9 of 13). Although subjects with prior impaired respiration were not common in the trials, they had higher rates of hypoventilation.
In addition, post-marketing reports have been received that describe opioid-naive post-operative patients who have experienced clinically significant hypoventilation and death with fentanyl transdermal system. Hypoventilation can occur throughout the therapeutic range of fentanyl serum concentrations, especially for patients who have an underlying pulmonary condition or who receive concomitant opioids or other CNS drugs associated with hypoventilation. The use of fentanyl transdermal system is contraindicated in patients who are not tolerant to opioid therapy.
Effects on the Gastrointestinal Tract and Other Smooth Muscle Fentanyl causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum. Digestion of food in the small intestine is delayed and propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased, while tone is increased to the point of spasm, resulting in constipation.
Other opioid-induced effects may include a reduction in biliary and pancreatic secretions, spasm of sphincter of Oddi, transient elevations in serum amylase, and opioid-induced esophageal dysfunction (OIED). Effects on the Cardiovascular System Fentanyl produces peripheral vasodilation, which may result in orthostatic hypotension or syncope. Manifestations of histamine release and/or peripheral vasodilation may include pruritus, flushing, red eyes, sweating, and/or orthostatic hypotension.
Histamine assays and skin wheal testing in clinical studies indicate that clinically significant histamine release rarely occurs with fentanyl administration. Clinical assays show no clinically significant histamine release in dosages up to 50 mcg/kg. Effects on the Endocrine System Opioids inhibit the secretion of adrenocorticotropic hormone (ACTH), cortisol, and luteinizing hormone (LH) in humans [see Adverse Reactions (6.2) ] .
They also stimulate prolactin, growth hormone (GH) secretion, and pancreatic secretion of insulin and glucagon. Use of opioids for an extended period of time may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility. The causal role of opioids in the clinical syndrome of hypogonadism is unknown because the various medical, physical, lifestyle, and psychological stressors that may influence gonadal hormone levels have not been adequately controlled for in studies conducted to date [see Adverse Reactions (6.2) ] .
Effects on the Immune System Opioids have been…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Fentanyl is an opioid agonist. Fentanyl interacts predominately with the opioid mu-receptor. These mu-binding sites are distributed in the human brain, spinal cord, and other tissues.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Fentanyl Transdermal System is supplied in cartons containing 5 individually packaged systems and is available as 12 mcg/hour*, 25 mcg/hour, 37.5 mcg/hour, 50 mcg/hour, 62.5 mcg/hour, 75 mcg/hour, 87.5 mcg/hour or 100 mcg/hour of fentanyl. The 12 mcg/hour* transdermal system is 3.13 cm 2 and contains 1.28 mg fentanyl. Each transdermal system consists of a translucent rectangular patch with rounded corners, printed with “Fentanyl 12 mcg/hr” and diagonal stripes in blue ink, on a removable release liner.
The patch is overlaid and underlaid with additional release liners, and is contained in a square pouch. The pouch is labeled with the lot number and expiration date. They are available as follows: NDC 0378-9119-98 carton containing 5 transdermal systems The 25 mcg/hour transdermal system is 6.25 cm 2 and contains 2.55 mg fentanyl.
Each transdermal system consists of a translucent rectangular patch with rounded corners, printed with “Fentanyl 25 mcg/hr” and diagonal stripes in blue ink, on a removable release liner. The patch is overlaid and underlaid with additional release liners, and is contained in a square pouch. The pouch is labeled with the lot number and expiration date.
They are available as follows: NDC 0378-9121-98 carton containing 5 transdermal systems The 37.5 mcg/hour transdermal system is 9.38 cm 2 and contains 3.83 mg fentanyl. Each transdermal system consists of a translucent rectangular patch with rounded corners, printed with “Fentanyl 37.5 mcg/hr” and diagonal stripes in blue ink, on a removable release liner. The patch is overlaid and underlaid with additional release liners, and is contained in a square pouch.
The pouch is labeled with the lot number and expiration date. They are available as follows: NDC 0378-9125-98 carton containing 5 transdermal systems The 50 mcg/hour transdermal system is 12.5 cm 2 and contains 5.10 mg fentanyl. Each transdermal system consists of a translucent rectangular patch with rounded corners, printed with “Fentanyl 50 mcg/hr” and diagonal stripes in blue ink, on a removable release liner.
The patch is overlaid and underlaid with additional release liners, and is contained in a square pouch. The pouch is labeled with the lot number and expiration date. They are available as follows: NDC 0378-9122-98 carton containing 5 transdermal systems The 62.5 mcg/hour transdermal system is 15.63 cm 2 and contains 6.38 mg fentanyl.
Each transdermal system consists of a translucent rectangular patch with rounded corners, printed with “Fentanyl 62.5 mcg/hr” and diagonal stripes in blue ink, on a removable release liner. The patch is overlaid and underlaid with additional release liners, and is contained in a square pouch. The pouch is labeled with the lot number and expiration date.
They are available as follows: NDC 0378-9126-98 carton containing 5 transdermal systems The 75 mcg/hour transdermal system is 18.75 cm 2 and contains 7.65 mg fentanyl. Each transdermal system consists of a translucent rectangular patch with rounded corners, printed with “Fentanyl 75 mcg/hr” and diagonal stripes in blue ink, on a removable release liner. The patch is overlaid and underlaid with additional release liners, and is contained in a square pouch.
The pouch is labeled with the lot number and expiration date. They are available as follows: NDC 0378-9123-98 carton containing 5 transdermal systems The 87.5 mcg/hour transdermal system is 21.88 cm 2 and contains 8.93 mg fentanyl. Each transdermal system consists of a translucent rectangular patch with rounded corners, printed with “Fentanyl 87.5 mcg/hr” and diagonal stripes in blue ink, on a removable release liner.
The patch is overlaid and underlaid with additional release liners, and is contained in a square pouch. The pouch is labeled with the lot number and expiration date. They are available as follows: NDC 0378-9127-98 carton containing 5 transdermal systems The 100 mcg/hour transdermal system is 25 cm 2 and contains…
📋 Description ▾
11 DESCRIPTION The system contains fentanyl, an opioid agonist, for transdermal administration. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hour per 6.25 cm 2 ). The composition per unit area of all transdermal system sizes is identical.
Strength (mcg/hour) Size (cm 2 ) Fentanyl Content (mg) 12 Nominal delivery rate is 12.5 mcg/hour 3.13 1.28 25 Nominal delivery rate per hour 6.25 2.55 37.5 9.38 3.83 50 12.5 5.10 62.5 15.63 6.38 75 18.75 7.65 87.5 21.88 8.93 100 25
10.20The molecular weight of fentanyl base is 336.5, and the molecular formula is C 22 H 28 N 2 O. The n‑octanol: water partition coefficient is 860:1. The pKa is 8.4.
The chemical name is N-Phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide. The structural formula is: Fentanyl transdermal system is a rectangular translucent system with rounded corners. “Fentanyl”, dosage strength and diagonal lines are printed in blue ink on each system. Each system is comprised of a polyester release liner and two functional layers.
Proceeding from the outer surface toward the surface adhering to skin, these functional layers are: 1) a backing layer of translucent polyolefin film with blue print; 2) a drug-in-adhesive layer containing fentanyl as the active ingredient and dimethicone NF and silicone adhesive as inactive ingredients. Before use, a polyester release liner covering the drug-in-adhesive layer is removed and discarded. Fentanyl transdermal systems are packaged with additional pieces of protective film above and below the system within each pouch.
These are discarded at the time of use. Fentanyl Structural Formula Parts of the Fentanyl Transdermal System
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use ). Storage and Disposal: Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store fentanyl transdermal system securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. Inform patients that leaving fentanyl transdermal system unsecured can pose a deadly risk to others in the home [see Warnings and Precautions (5.1 , 5.3) , Drug Abuse and Dependence (9.2) ] .
Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly. Expired, unwanted, or unused fentanyl transdermal systems should be disposed of by folding the patch so that the adhesive side of the patch adheres to itself, and immediately flushing down the toilet (if a drug take-back option is not readily available) [see Instructions for Use ] . Inform patients that they can visit www.fda.gov/drugdisposal for a complete list of medicines recommended for disposal by flushing, as well as additional information on disposal of unused medicines.
Addiction, Abuse, and Misuse: Inform patients that the use of fentanyl transdermal system, even when used as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see Warnings and Precautions (5.1) ] . Instruct patients not to share fentanyl transdermal system with others and to take steps to protect fentanyl transdermal system from theft or misuse. Life-Threatening Respiratory Depression: Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting fentanyl transdermal system or when the dosage is increased, and that it can occur even at recommended dosages.
Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help right away in the event of a known or suspected overdose [see Warnings and Precautions (5.2) ]. Accidental Exposure: Inform patients that accidental exposure, especially in children, may result in respiratory depression or death [see Warnings and Precautions (5.3) ] . Fentanyl transdermal system can be accidentally transferred to children.
Instruct patients to take special precautions to avoid accidental contact when holding or caring for children. Instruct patients that, if the patch dislodges and accidentally sticks to the skin of another person, to immediately take the patch off, wash the exposed area with water and seek medical attention for the accidentally exposed individual as accidental exposure may lead to death or other serious medical problems. Interactions with Benzodiazepines and Other CNS Depressants: Inform patients and caregivers that potentially fatal additive effects may occur if fentanyl transdermal system is used with benzodiazepines or other CNS depressants, including alcohol (e.g., non-benzodiazepine sedative/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), and other opioids), and not to use these concomitantly unless supervised by a healthcare provider [see Warnings and Precautions (5.4) , Drug Interactions (7) ] .
Patient Access to an Opioid Overdose Reversal Agent for the Emergency Treatment of Opioid Overdose: Inform patients and caregivers about opioid overdose reversal agents (e.g., naloxone, nalmefene). Discuss the importance of having access to an opioid overdose reversal agent, especially if the patient has risk factors for overdose (e.g., concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose) or if there are household members (including children) or other close contacts at risk for accidental ingestion or opioid overdose.
Discuss with the patient the options for obtaining a…
💬 Medication Guide ▾
Medication Guide Fentanyl Transdermal System, CII (fen' ta nil) Fentanyl transdermal system is: • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage severe and persistent pain that requires an extended treatment period with a daily opioid pain medicine, in people who are already regularly using opioid pain medicine when other pain medicines do not treat your pain well enough or you cannot tolerate them. • A long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death.
Even if you use your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death. • Not to be used on an “as needed” basis. Important information about fentanyl transdermal system: • Get emergency help or call 911 right away if you use too many fentanyl transdermal systems (overdose). When you first start using fentanyl transdermal system, when your dose is changed, or if you use too many (overdose), serious or life-threatening breathing problems that can lead to death may occur.
Ask your healthcare provider about medicines like naloxone or nalmefene that can be used in an emergency to reverse an opioid overdose. • Using fentanyl transdermal system with other opioid medicines, benzodiazepines, gabapentinoids (gabapentin or pregabalin), alcohol, or other central nervous system depressants (including street drugs) may cause severe drowsiness, decreased awareness, breathing difficulties, with slow or shallow breathing, coma, and death. • Never give anyone else your fentanyl transdermal system. They could die from using it.
Selling or giving away fentanyl transdermal system is against the law. • Store fentanyl transdermal system, securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. • If the patch accidentally sticks to a family member while in close contact, take the patch off, wash the area with water, and get emergency help right away because an accidental exposure to fentanyl transdermal system can lead to death or other serious medical problems. • Dispose of expired, unwanted, or unused fentanyl transdermal system, by folding the patch so that the adhesive side of the patch adheres to itself, and immediately flushing down the toilet (if a drug take-back option is not readily available) [see Instructions for Use] .
Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines. Do not use fentanyl transdermal system if you have: • severe asthma, trouble breathing, or other lung problems. • a bowel blockage or have narrowing of the stomach or intestines. Before applying fentanyl transdermal system, tell your healthcare provider if you have a history of: • head injury, seizures • problems urinating • liver, kidney, thyroid problems • pancreas or gallbladder problems • abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems.
Tell your healthcare provider if you: • notice your pain getting worse. If your pain gets worse after you use fentanyl transdermal system, do not use more of fentanyl transdermal system without first talking to your healthcare provider. Talk to your healthcare provider if the pain that you have increases, if you feel more sensitive to pain, or if you have new pain after using fentanyl transdermal system. • have a fever • are pregnant or planning to become pregnant.
Use of fentanyl transdermal system for an extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. • are breastfeeding. Not recommended during treatment with fentanyl transdermal system. It may harm your baby. • are living in a household where there are small children or someone who has abused street or prescription drugs. • are taking prescription or over-the-counter medicines, vitamins, or herbal supplements.
Using fentany…